Calculating the sample size required for developing a clinical prediction model.
Richard D Riley, Joie Ensor, Kym I E Snell...
https://pubmed.ncbi.nlm.nih.gov/32188600/Actively Recruiting
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2026-01-22
600
Participants Needed
2
Research Sites
N/A
Total Duration
Papillary thyroid carcinoma PTC is the most common type of thyroid cancer, and many early-stage cases classified as T1N0M0 tumor size 2 cm or less, no clinical lymph node or distant metastasis are being diagnosed due to widespread use of ultrasound. The burden of central lymph node metastasis CLNM greatly influences individualized treatment plans, as different levels of metastasis require different surgical approaches. Conventional imaging methods have limited accuracy in detecting CLNM, leading to possible overtreatment or undertreatment of patients with T1N0M0 PTC. This multicenter retrospective study enrolled 600 patients with T1N0M0 PTC who underwent surgery between June 2018 and June 2025. Before surgery, all patients had dynamic contrast-enhanced ultrasound CEUS of the thyroid and lymph nodes, which provides detailed real-time images of tissue blood flow. Experienced ultrasound physicians analyzed CEUS features to predict lymph node metastasis burden, dividing patients into high-burden, low-burden, and non-metastasis groups. The study used statistical models to identify key CEUS predictors and created a combined model to assess diagnostic accuracy. Participants had their CEUS images analyzed independently and their lymph node status confirmed by pathology after surgery. The study measured the models accuracy using area under the curve AUC and other diagnostic values like sensitivity and specificity. Researchers also evaluated the clinical usefulness of the model to better guide treatment decisions. This approach aims to improve preoperative assessment of lymph node metastasis burden, enabling more precise and personalized treatment for patients with T1N0M0 PTC.
CONDITIONS
Preoperative Prediction of Lymph Node Metastasis in T1N0M0 Papillary Thyroid Carcinoma by Using Contrast-enhanced Ultrasound
J
Jingliang Ruan, Doctoral Degree
X
Xinmin Xiao, Master's Degree
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to several days before surgery
Participants undergo preoperative conventional ultrasound and contrast-enhanced ultrasound (CEUS) imaging of the thyroid and central lymph nodes to assess lymph node metastasis burden.
1 to 2 imaging visits
Duration - Single day procedure
Participants undergo thyroidectomy (lobectomy or total) with central lymph node dissection based on clinical assessment.
1 surgical visit (in-person)
Duration - Within days to weeks after surgery
Pathological examination of surgical specimens confirms papillary thyroid carcinoma and lymph node metastasis burden to classify participants into metastasis groups.
1 visit (in-person or specimen processing)
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Lead Sponsor